This article was originally featured on Undark.
Mark Turner has worked in pediatrics for more than 30 years, and he’s tired of telling parents there’s nothing he can do for their children. Very few medicines are developed with young people in mind, he said. “It’s just very difficult, watching them be sick, watching babies die.”
Turner is referring to the lack of research into how different medications perform in children. When drugs get approved, it’s usually on the basis of how they function in adults. This holds true for nearly all conditions, including mental health disorders, cancer, and rare diseases.
As a result, children are usually prescribed medication “off-label,” meaning the drug is being used differently from what’s specifically outlined on the package insert. Most drugs used for newborns are given off-label, as well as about half of those prescribed for older children, said Vivianna Guzman, executive director of I-ACT for Children, a nonprofit seeking to improve children’s access to drugs.
This can leave physicians and parents with a difficult dilemma. Although the vast majority of drugs that are used off-label for kids appear to be safe, the lack of proper testing puts children at a relatively higher risk of side effects than adults, experts told Undark. And medications that work well in adults might also be less effective in young people. Further, in dire situations, when the need for medication is urgent, physicians and parents may find that they lack access to clinical trials, which historically excluded children. The reasons for all of this, experts said, are both practical and financial.
The American Academy of Pediatrics has stressed that off-label prescribing does not necessarily entail great risk. Rather, it means that the medication has not met FDA guidelines, which call for studies to be conducted in the population that will use the drug: in this case, children.
Absent such evidence,…
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